Multiple SclerosisNCT03927092
Reliability and Validity of the Turkish Version of the Multiple Sclerosis Knowledge Questionnaire
An observational study of Multiple Sclerosis, run by Ege University.
Trial summary
Multiple Sclerosis Knowledge Questionnaire (MSKQ) is a 25-item self administered questionnaire assessing a patient's level of knowledge regarding multiple sclerosis (MS). Turkish translation of the questionnaire was prepared and participants in the annual patient education seminar in the investigators' university… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Multiple Sclerosis Knowledge Questionnaire
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed as having multiple sclerosis.
Who may be able to join
- Diagnosed as having Multiple Sclerosis
- Attends the annual patient education seminar at the investigators' university hospital
- Older than 18 years of age
- Can read and write
Who cannot join
- Does not accept to answer the questionnaire
- Unable to answer the questions due to a cognitive impairment
About this study
Multiple Sclerosis Knowledge Questionnaire (MSKQ) is a 25-item self administered questionnaire assessing a patient's level of knowledge regarding multiple sclerosis (MS). Turkish translation of the questionnaire was prepared and participants in the annual patient education seminar in the investigators' university hospital were asked to answer these questions before and after the seminar.Their results were analysed to assess their level of knowledge about their disease.
Read the detailed description
Multiple sclerosis knowledge questionnaire was developed in Italy (1) and was reported to be useful in measuring patients' level of knowledge about their disease. The English version of the questionnaire was translated into Turkish by three physicians than back translated into English by two separate linguists. Initially 5 MS patients were asked to answer this first version of the questionnaire and report any difficulties in understanding the items. Their feedback was used to give the questionnaire its final shape. For the validation stage, patients that were diagnosed as having MS and who attended the annual MS patient education seminar were enrolled into the study. They answered the questions twice, before and after the seminar. Their answers were analysed to measure their level of knowledge about their disease.
- Conditions
- Multiple Sclerosis
- Being tested
- Multiple Sclerosis Knowledge Questionnaire
- Keywords
- multiple sclerosis, surveys and questionnaires, diagnostic self evaluation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Sclerosis Knowledge QuestionnaireOther
A 25-item self-administered questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis patients | Patients that attended an annual patient education seminar at the investigators' university hospital were asked to fill out the Turkish version of the Multiple Sclerosis Knowledge Questionnaire Receives: Other: Multiple Sclerosis Knowledge Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
reliability of the questionnaire
Internal consistency was evaluated by the coefficient alpha (α) or Cronbach's coefficient, and if the Cronbach's coefficient value was greater than 0.7, it was considered as an acceptable internal consistency
Measured: 1 day
Secondary outcomes (1)
Number of correct answers
To assess the distribution of correct and false answers and the levels of significance, Chi-square test was used. To compare the two questionnaires answered by the same patient before and after the seminar Wilcoxon signed-rank test was used.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study startMay 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Cinar, Ege University
- Investigators
- Ece Cinar, M.D., Principal investigator, Ege University School of MedicineYesim Akkoc, M.D., Study director, Ege University School of MedicineFunda Calis, M.D., Principal investigator, Ege University School of MedicineMusa Baklaci, M.D., Principal investigator, Ege University School of MedicineOzgul Ekmekci, M.D., Principal investigator, Ege University School of MedicineAyse N Yuceyar, M.D., Principal investigator, Ege University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927092
- Sponsor's protocol ID
- 16-4.1/19
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giordano A, Uccelli MM, Pucci E, Martinelli V, Borreani C, Lugaresi A, Trojano M, Granella F, Confalonieri P, Radice D, Solari A; SIMS-Trial group. The Multiple Sclerosis Knowledge Questionnaire: a self-administered instrument for recently diagnosed patients. Mult Scler. 2010 Jan;16(1):100-11. doi: 10.1177/1352458509352865. Epub 2009 Dec 7.
PubMed 19995834
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Multiple Sclerosis Knowledge Questionnaire
- ClinicalTrials.gov ID
- NCT03927092
- Acronym / sponsor ID
- 16-4.1/19
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, surveys and questionnaires, diagnostic self evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple Sclerosis Knowledge Questionnaire (MSKQ) is a 25-item self administered questionnaire assessing a patient's level of knowledge regarding multiple sclerosis (MS). Turkish translation of the questionnaire was prepared and participants in the annual patient education seminar in the investigators' university hospital were asked to answer these questions before and after the seminar.Their results were analysed to assess their level of knowledge about their disease.
Detailed description
Multiple sclerosis knowledge questionnaire was developed in Italy (1) and was reported to be useful in measuring patients' level of knowledge about their disease. The English version of the questionnaire was translated into Turkish by three physicians than back translated into English by two separate linguists. Initially 5 MS patients were asked to answer this first version of the questionnaire and report any difficulties in understanding the items. Their feedback was used to give the questionnaire its final shape. For the validation stage, patients that were diagnosed as having MS and who attended the annual MS patient education seminar were enrolled into the study. They answered the questions twice, before and after the seminar. Their answers were analysed to measure their level of knowledge about their disease.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis patients | – | Other: Multiple Sclerosis Knowledge QuestionnairePatients that attended an annual patient education seminar at the investigators' university hospital were asked to fill out the Turkish version of the Multiple Sclerosis Knowledge Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as having multiple sclerosis.
Key inclusion criteria (4 listed)
- Diagnosed as having Multiple Sclerosis
- Attends the annual patient education seminar at the investigators' university hospital
- Older than 18 years of age
- Can read and write
Key exclusion criteria (2 listed)
- Does not accept to answer the questionnaire
- Unable to answer the questions due to a cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Sclerosis Knowledge QuestionnaireA 25-item self-administered questionnaire | Other | Multiple Sclerosis patients |
Primary outcome
reliability of the questionnaire
Time frame: 1 day
Internal consistency was evaluated by the coefficient alpha (α) or Cronbach's coefficient, and if the Cronbach's coefficient value was greater than 0.7, it was considered as an acceptable internal consistency
1 secondary outcome
Number of correct answers
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Background: PubMed 19995834Giordano A, Uccelli MM, Pucci E, Martinelli V, Borreani C, Lugaresi A, Trojano M, Granella F, Confalonieri P, Radice D, Solari A; SIMS-Trial group. The Multiple Sclerosis Knowledge Questionnaire: a self-administered instrument for recently diagnosed patients. Mult Scler. 2010 Jan;16(1):100-11. doi: 10.1177/1352458509352865. Epub 2009 Dec 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ece Cinar, M.D. principal investigator
Ege University School of Medicine
Yesim Akkoc, M.D. study director
Ege University School of Medicine
Funda Calis, M.D. principal investigator
Ege University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reliability of the questionnaire (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03927092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.